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Effect of Roflumilast on Airway Blood Flow as an Expression of Airway Inflammation in COPD

NCT02097992 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2017-11-24

Study results available
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Summary

The objectives of the proposed study are to determine 1) the effect of a single dose of Roflumilast on airway blood flow (Qaw) (study period 1) and 2) the effect of long-term Roflumilast treatment on airway blood flow reactivity delta Qaw)(study period 2) in patients with stable COPD who use ICS regularly.

Conditions

  • COPD

Interventions

DRUG

Roflumilast Placebo

Placebo pill

DRUG

Roflumilast

500 Ug ORAL TABLET

Sponsors & Collaborators

  • Forest Laboratories

    collaborator INDUSTRY

  • University of Miami

    lead OTHER

Principal Investigators

  • Adam Wanner, MD · University of Miami

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2015-07-31
Completion
2015-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02097992 on ClinicalTrials.gov